It's Standards Time

The clinical trials space these days is an alphabet soup of technologies: CTMS (clinical trial management systems); CDM (clinical data management); CDR (clinical data repositories); eCTD (electronic common technical document); and many more. But the technology with the most promise for transforming the way clinical trials are performed (and for driving everyone mad throughout implementation) is EDC—electronic data capture. It's taken more than a decade, but today most big pharma companies—and a fair number of smaller ones—are using some form of EDC in clinical trials. The early adopters might have experienced some growing pains, but the benefits seem to be outweighing the high cost of implementation. Few companies would consider going back to paper-based trials.

"Technology is primarily what's driving improved operational efficiency in clinical development today," says Gary Tyson, senior vice president, practice area leader at consulting firm Campbell Alliance. "And EDC is probably the one technology that more companies are embracing for the first time than any other tool."

The key benefits of EDC are well known and hard to ignore: speed and efficiency. With paper trials, it takes, on average, three months to close out after the last subject is accounted for. With an EDC study, the average is closer to three weeks. Unlike paper trials, doctors can review test information moments after it's entered into the system, and data can be queried as it is processed. At the end of the trial, the only difference between the last subject and the middle subject is that it's just the last new piece of data entering the database.

Guiding Light

So why hasn't every pharma company jumped at the chance to implement EDC? One word: standards. There aren't any.

Or, more accurately, there aren't enough. With more than 30 companies offering data-capture systems, not much guidance to date from FDA, and a strong build-it-yourself tradition at many pharma companies, EDC systems vary considerably. And that creates problems: problems in getting the various components of the clinical trials system to talk with each other and problems training and managing doctors and others at the actual research sites. In the past, investigators and staffs have been forced to learn and relearn EDC systems with little consistency in how they operate. That needs to change.

This is not to say there's been no progress on standards. Over the past few years, some key steps have been taken. Most recently, in May, FDA released Computerized Systems Used in Clinical Investigations, its latest guidance for industry on the subject. The 10-page document is general in scope and offers only broad criteria: limiting access to only key users, ensuring that there is an audit trail, using date stamps and security safeguards, properly training users, and the like.

And, of course, the not-for-profit Clinical Data Interchange Standards Consortium (CDISC) is continuing its standards-setting work, with an eye toward providing integrated standards for the entire clinical research process by 2010. Five standards are ready for implementation, most notably the Study Data Tabulation Model (SDTM), which was designed to support the metadata flow from operational database to regulatory submission. CDISC recently announced that it would lead the Clinical Data Acquisition Standards Harmonization (CDASH) project, a project to respond to one of FDA's Critical Path "opportunities" by developing a standard approach to case report forms (CRFs). This project, in conjunction with another CDISC initiative to ease importation of CRF data into electronic medical records, should go a long way toward integrating clinical research and medical practice.

But results are months or years off, and some pharma companies need a quicker, if temporary, solution. Several pharma companies, including Bristol-Meyers Squibb, have formed a consortium with their mutual EDC vendor, Oracle, to find ways to harmonize some of the training for remote sites.